Preparation clean room installation
Preparation clean room installation
In order to meet the requirements of GMP, equipment installation is an important part. First of all, the layout of the equipment should be reasonable, the installation should not affect the quality of the product, and the installation distance should be convenient for production operation, disassembly, cleaning and maintenance. , and avoid errors and cross-contamination...
Text label: preparation clean pharmaceutical cleanroom, preparation clean pharmaceutical cleanroom installation, clean workshop design and decoration
Preparation clean room installation
In order to meet the requirements of GMP, equipment installation is an important part. First of all, the layout of the equipment should be reasonable, the installation should not affect the quality of the product, and the installation distance should be convenient for production operation, disassembly, cleaning and maintenance. , and avoid errors and cross-contamination; when equipment passes through different clean areas, in addition to considering fixing, a reliable sealing partition device should also be used to prevent pollution; between rooms with different cleanliness levels, such as when using conveyor belts to transfer materials, To prevent cross-contamination, the conveyor belt should not pass through the partition wall, but should be conveyed in sections on both sides of the partition wall, and the transmission device sent to the sterile area must be conveyed in sections; light and flexible conveying tools, such as conveyor belts, trolleys, etc., should be designed or selected. Chutes, flexible nozzles, closed hoppers, etc. are used to assist the connection between equipment; for equipment that generates noise and vibration, noise reduction and vibration isolation devices should be used respectively to improve the operating environment. During dynamic operation, the noise in the clean pharmaceutical cleanroom should not exceed the flow rate. 70dB; the surface of the insulation layer of the equipment must be smooth and clean, no particulate matter should fall off, the surface should not be plastered with asbestos cement, and should be protected by a metal shell.
Contamination of microorganisms, particles and pyrogens should be avoided as far as possible in the production process of preparations. Since the production of sterile products should be batched, filled and sealed in a high clean environment, and there are many variable influencing factors in the process, it is necessary to The production of sterile products puts forward special requirements, in which the quality assurance system occupies a particularly important position. An important embodiment in the design of preparation equipment is the sealing of the production process and the implementation of isolation technology. In the production of aseptic products, in order to avoid contamination, an important measure is to design and establish an isolation area around the preparation equipment of the filling line, isolate the operators from the filling area, and adopt a thorough isolation technology and automatic control system to avoid To ensure that the production of sterile products is pollution-free, isolation technology has become an important part of the design, production and transformation of sterile product production workshops and equipment; to ensure reasonable equipment design and maintain equipment reliability; to meet ergonomic requirements and ideals for the isolation system; With precise operation control; tight seal between the equipment and the isolation device, the equipment is suitable for clean workshops; materials resistant to disinfection, sterilization and cleaning are selected; easy to clean and sterilize in place. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for preparation clean workshops and sterile workshops.
Preparation clean plant equipment should be easy to clean, especially when changing products, all equipment, pipes and containers must be thoroughly cleaned and sterilized according to regulations to eliminate active ingredients and their derivatives, excipients, detergents, lubricants , cross-contamination of environmental pollutants, eliminate foreign matter remaining in the flushing water and foreign matter and insoluble particles released during the operation of the equipment, reduce or eliminate the pollution of microorganisms and pyrogens; the design of preparation equipment should be designed and established in-situ cleaning and in-situ cleaning Sterilized cleaning and sterilization system to solve in-situ cleaning and in-situ sterilization of inconvenient moving equipment.
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